This invention relates to a medical treatment method and an associated device. The method may be used in the treatment of such conditions as esophageal varices, hemorrhoids, tumors, and wounds or holes particularly in internal tissues.
Many medical conditions involve swollen tissues which attain such a size as to inhibit or interfere with one or more necessary physiological functions. An example of such swollen tissues are varices of the digestive tract. Gastric and esophageal varices are a devastating complication of portal hypertension. To treat such bleeding varices, it is necessary at times to use a long tube with two inflatable balloons at a distal end, known as a xe2x80x9cBlakemore Tube.xe2x80x9d In using this device to stop the flow of blood in the stomach, the tube is blindly inserted into the esophagus until it is believed that the most distal of the two balloons is located in the patient""s stomach. That balloon is then inflated and the tube placed in tension (e.g., via attachment to a weight outside of the patient) to pull the inflated balloon against the stomach wall at the gastroesophageal junction. In the event that bleeding esophageal varices are to be treated, the relatively proximal balloon is also inflated.
The rate of complications in the use of the Blakemore tube is immense. The complications result mainly from poor placement or slippage of the tube. In addition, the relatively proximal balloon sometimes erodes into the esophagus, causing bleeding, perforation and necrosis of the esophagus.
Another kind of swollen internal tissues, namely, hemorrhoids, are located at the downstream end of the digestive tract. Hemorrhoids are a common malady which causes substantial pain and suffering to millions of people. The best conventional treatment for this affliction is a soaking of the hemorrhoidal tissues in a hypertonic bath, such as a solution of Epsom salts. However, this treatment is not especially effective. A need exists for a more convenient and yet effective treatment for hemorrhoids.
Certain cancers represent yet another kind of swollen tissues. Once cancer has reached the tumor stage, where lumps of cancerous tissues are detectable either directly through touch and vision or indirectly with the aid of MRI and CAT scanners, the principal treatment is surgical. The victim is operated on and the tumor cut out of the body. Frequently, the location and size of the tumor are such that surgical removal results in a severe impairment to the patient""s body and lifestyle. For example, surgical removal of a large tumor in a femur frequently results in an amputation.
The operations for surgically removing tumors are nearly universally open incision type operations. These operations are naturally debilitating and require extensive post surgical care. For these reasons, the costs of conventional open incision surgery are enormous.
Although minimally invasive procedures such as laparoscopic or thoracoscopic surgery have increased at geometric rates in frequency of performance, minimally invasive surgery for the treatment of cancer has not been employed. Of course, other kinds of minimally invasive techniques such as chemotherapy and radiation treatment are widely practiced. However, these techniques have substantial debilitating side effects. Patients must suffer significantly in virtually every case.
Nevertheless, minimally invasive techniques are the future of medicine. Patient trauma and hospitalization time are reduced. In addition, costs and expenses are decreased.
Internal wounds such as perforations of internal organs are also generally treated by open surgery. Such wounds may be the result of traumas. A blunt trauma may cause a rupture, for instance, of the spleen and consequent internal bleeding.
An object of the present invention is to provide a method for treating swollen tissues including, but not limited to, hemorrhoidal tissues, esophageal or gastric varices, and tumors.
It is a further object of the present invention to provide such a method which is less invasive than conventional open-incision surgical techniques.
It is another object of the present invention to provide such a method which is less expensive than one or more conventional techniques.
A more specific object of the present invention is to provide a treatment technique which is of little danger to the patient.
A related object of the present invention is to provide an associated device or assembly for treating such swollen tissues.
These and other objects of the present invention will be apparent from the drawings and descriptions herein. It is to be noted that any one of the above objects may be attained in one or more embodiment of the invention disclosed herein. No one embodiment need attain all of the objects of the invention.
A medical treatment method comprises, in accordance with the present invention, injecting at least one first magnetic element into organic tissues of a patient on one side of a feature to be closed or collapsed, injecting at least one second magnetic element into the organic tissues of the patient on an opposite side of the feature to be closed or collapsed, and, by virtue of a magnetic attraction between the first magnetic element and the second magnetic element, drawing the organic tissues of the patient together to close or collapse the feature.
In accordance with another aspect of the present invention, the feature to be treated by the method includes a blood vessel. The treatment technique in this circumstance serves in part to constrict the blood vessel. Other tissues about the blood vessel may also be clamped or collapsed owing to the magnetic attraction between the injected elements. For instance, where the blood vessel is in esophageal varices, the drawing of the organic tissues of the patient together includes a constricting or reducing of the varices. Thus, in one simple procedure, the esophagus is opened and the blood vessels in the varices are closed off, preventing bleeding into the digestive tract.
A procedure for constricting swollen internal tissues in accordance with the present invention is preferably executed in a minimally invasive manner. Thus, where the swollen target tissues are esophageal varices, an endoscope is inserted into the patient""s esophagus and the magnetic elements are ejected from a biopsy channel of the endoscope. The optics of the endoscope are used to visually detect the varices and select a point of entry on the varices for the magnetic elements.
Where target swollen tissues are a hemorrhoid, the drawing of the organic tissues of the patient together result in a size reduction of the hemorrhoid, as well as a constricting of one or more blood vessels of the hemorrhoid.
The organic tissues into which the magnetic elements are injected may be a tumor. In that case, the drawing together of the tissues entails an interrupting of a blood supply of the tumor. The attraction between the magnetic elements serves to at least partially collapse the blood vessels which feed the tumor. In many cases, the magnetic elements may be injected into a tumor via a minimally invasive procedure. A needle may be used to inject the magnetic elements.
In general, where the target tissues are swollen tissues such as varices, a tumor, or hemorrhoids, it is not necessary to identify and locate particular blood vessels which are to be closed or collapsed. Instead, the magnetic elements are injected into the target tissues in such numbers and with such a density that blood vessels located in the target tissues are naturally constricted by the movement of the injected magnetic elements under the magnetic attractive forces.
In some cases, the target is an identifiable wound or opening. In that case, a permanent magnet is injected into tissues on one side of the wound or opening, while another permanent magnet or one or more magnetizable particles (generally metallic) are injected on an opposite side of the wound or opening. The magnetic attraction results in a constricting of the tissues and a closure of the wound or opening.
Accordingly, it is contemplated that at least one of the magnetic elements is a permanent magnet. The other magnetic elements may include one or more permanently magnetized particles, as well as one or more magnetizable particles. The magnetizable particles may be made of a metal such as iron or steel or may be made of a polymeric material in which magnetic atoms are embedded. The magnetic elements may be formed at one end with a point for facilitating entry into the target tissues and are of a suitable size for exerting a compressive force on the target tissues. In some case, metal filings may be used. Filings generally have sharp points or edges facilitating injection into organic tissues.
It is to be noted that where the magnetic elements or particles are injected into digestive tract tissues, a subsequent dislodgement of the particles merely results in their being flushed from the body with excreted materials.
A medical treatment device or instrument comprises, in accordance with the present invention, an elongate tube housing a plurality of magnetic elements, and a pressure applicator operatively connected to the tube for exerting a force on the magnetic elements to eject the magnetic elements from an end of the tube into organic tissues of a patient.
The pressure applicator may simply be a plunger. Alternatively or additionally, the magnetic elements may be disposed in a matrix of a biocompatible or bioabsorbable gel. Pressure placed on the gel from a handle or proximal end of the instrument, e.g., via a plunger or pump, forces the gel and the ensconced magnetic elements from the free or distal end of the instrument into the target tissues. Before the ejection of the magnetic elements from the tube of the treatment device, the free or distal end of the instrument is positioned in contact with the target tissues. Generally, this contact is with only an external surface of the target tissues. However, it is also possible for the distal end of the instrument to be partially inserted into the target tissues.
In a particular embodiment of a medical treatment device in accordance with the present invention, the device includes a pair of attached parallel tubes, with unmagnetized metal particles disposed in one of the tubes and permanently magnetized magnetic elements disposed in the other tube. Each tube is provided with a respective pressure applicator for exerting a force on the respective magnetic elements to eject them into organic tissues of the patient. In this embodiment, the permanently magnetized magnetic elements may be disposed in the respective tube so that like poles of the permanently magnetized magnetic elements face one another.
The present invention provides, inter alia, a method for treating swollen tissues including, but not limited to, hemorrhoidal tissues, esophageal or gastric varices, and tumors. This method is less invasive and less expensive than conventional open-incision surgical techniques.